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GE Healthcare Technical Publications 5128706–1–100 Revision 1 SENOGRAPHE DMR+ Pre–Installation Manual do not duplicate Copyright 2006 by General Electric Co.
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Geräte bedienen oder sich selbst und andere Personen deren Bestrahlung aussetzen können. Vor Inbetriebnahme dieses Apparats sollte sich das qualifizierte und befugte Bedienungspersonal mit den geltenden Kriterien für den ge- fahrlosen Strahleneinsatz durch sorgfältiges Studium des Hefts Nr. 26 der Internationalen Kommission für Strahlenschutz (ICRP) vertraut...
GE Healthcare SENOGRAPHE DMR+ REV 1 pim 5128706–1–100 TABLE OF CONTENTS CHAPTER TITLE PAGE REVISION HISTORY ............
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GE Healthcare SENOGRAPHE DMR+ REV 1 pim 5128706–1–100 TABLE OF CONTENTS (CONT.) CHAPTER TITLE PAGE 4–5 Use Limitation ............
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GE Healthcare SENOGRAPHE DMR+ REV 1 pim 5128706–1–100 INSTRUCTIONS CONCERNING SAFETY WARNING X–RAY EQUIPMENT IS DANGEROUS TO BOTH PATIENT AND OPERATOR UNLESS ESTABLISHED SAFE EXPOSURE FACTORS ARE STRICTLY OBSERVED Though this apparatus is built to the highest standards of electrical and mechanical safety, the useful x–ray beam becomes a source of danger in the hands of the...
GE Healthcare SENOGRAPHE DMR+ REV 1 pim 5128706–1–100 REVISION HISTORY DATE REFERENCE REASON FOR CHANGE New release based on document 2270822–100. November 29, 2004 5128706–100 rev. 1 Added information on compliance with IEC 601–1–2 Edition 2 New release based on document 5128706–100.
GE Healthcare SENOGRAPHE DMR+ REV 1 pim 5128706–1–100 SECTION 1 PURPOSE AND SCOPE OF THIS MANUAL This planning direction provides pre–installation data for the SENOGRAPHE DMR. It considers only product related pre–installation. SECTION 2 RESPONSIBILITY OF PURCHASER SECTION 3 PRODUCT IDENTIFICATION Components of the SENOGRAPHE DMR covered by this pre–installation manual comprise:...
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GE Healthcare SENOGRAPHE DMR+ REV 1 pim 5128706–1–100 OPTIONAL EQUIPMENT Stereotix 2. Accessory storage device. 24 x 30 Bucky + COMPRESSION PADDLE. Hydraulic chair. Rad shield 2 or 3. DATAFLASH. 1–4...
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GE Healthcare SENOGRAPHE DMR+ REV 1 pim 5128706–1–100 TABLE 1-1 PRODUCT STRUCTURE PRODUCT COMPLIES WITH THE FOLLOWING REGULATIONS: IEC601.2.7; UL187; CSA No. 22.114; CRF21 Part 1020.30; and NFC74100. IEC. 801.2; EN 61000–4–2 SENOGRAPHE DMR V2+ WITH XRAY PROTECTIVE SHIELD ACCESSORIES...
GE Healthcare SENOGRAPHE DMR+ REV 1 pim 5128706–1–100 SECTION 2 STRUCTURAL REQUIREMENTS THE GANTRY MUST BE ANCHORED TO THE FLOOR IF STEREOTIX 2 IS USED. WARNING 2–1 Floor mounting The stand column is placed directly om‘n the floor. The floor must be stable and flat, and...
GE Healthcare SENOGRAPHE DMR+ REV 1 pim 5128706–1–100 SECTION 3 ELECTRICAL REQUIREMENTS 3–1 Line voltage specifications Single–phase input voltage: - 200/208/220/240/380/415 V (±10%). 3–2 Line frequency specifications 50 or 60 Hz (±1 Hz). 3–3 kVA load characteristics 8.5 kVA for exposures up to 4.5 s.
GE Healthcare SENOGRAPHE DMR+ REV 1 pim 5128706–1–100 3–5 Line supply cable The line supply cable comprises of two supply wires and a ground cable (i.e. 3 x AWG 10 (5.32 )) with the following actual/usable lengths: - Total length = 7 m (23'), - Usable length = 6.5 m (21'-4").
GE Healthcare SENOGRAPHE DMR+ REV 1 pim 5128706–1–100 NEC 1993 Section 517–73 (a) Item 1: The ampacity of supply branch circuit conductors and the current rating of overcurrent protective devices shall not be less than 50 percent of the momentory rating or 100 percent of the long-time rating, whichever is greater.
GE Healthcare SENOGRAPHE DMR+ REV 1 pim 5128706–1–100 SECTION 4 IEC60601-1-2 ELECTROMAGNETIC STANDARDS COMPLIANCE 4–1 General This equipment complies with the IEC60601-1-2 Edition 2 EMC standard for medical devices. The Senographe Equipment or System is suitable for use in electromagnetic environments as defined in the limits and recommendations given in the following tables: Emission Compliance level and limits (Table 2–1).
GE Healthcare SENOGRAPHE DMR+ REV 1 pim 5128706–1–100 4–3 Electromagnetic Immunity The Senographe is suitable for use in the specified electromagnetic environment. The purchaser or user of the Senographe should ensure that it is used in an electromagnetic environment as described below: TABLE 2–2...
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GE Healthcare SENOGRAPHE DMR+ REV 1 pim 5128706–1–100 TABLE 2–3 ELECTROMAGNETIC IMMUNITY –PART 2 Immunity Compliance Electromagnetic Environment Test 60601-1-2 Level Test Level ] 3 V At this disturbance level the monitor image may present some slight flicker. If this occurs, the monitor may be removed from...
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GE Healthcare SENOGRAPHE DMR+ REV 1 pim 5128706–1–100 4–4 Recommended Separation Distances for Portable and Mobile RF Communications Equipment IEC 60601-1-2 TABLE 2–4 RECOMMENDED SEPARATION DISTANCES Frequency of 150KHz to 26 26 MHz to 80 MHz 80 MHz to 800 800 MHz to 2.5...
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GE Healthcare SENOGRAPHE DMR+ REV 1 pim 5128706–1–100 The Senographe is primarily intended for use in non–domestic environments, and not connected directly to the public mains supply network. It is primarily intended for use in environments (such as hospitals) with a dedicated supply system, and in an X–ray shielded room.
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GE Healthcare SENOGRAPHE DMR+ REV 1 pim 5128706–1–100 SECTION 5 INSITE CONNECTION The Senographe DMR will use the Generic EDM (Equipment Diagnostic Monitor) when it is available (1st quarter 1996). The Generic EDM is supplied as a Service option, in a separate cabinet.
GE Healthcare SENOGRAPHE DMR+ REV 1 pim 5128706–1–100 SECTION 2 MOUNTING REQUIREMENTS Given that the Senographe DMR has a modular design, its optimal use depends on the relative position of the modules (see the Installation Plan prepared for each site).
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GE Healthcare SENOGRAPHE DMR+ REV 1 pim 5128706–1–100 ILLUSTRATION 3-9 ISODOSE CURVE 50MSEV Section at 1,5m from the floor 40Kv, 4000mAs in 1 hour, 2000h/year, Mo track, large focus, Al filter, exposure on plexiglass insert (3 cm) 3–12...
GE Healthcare SENOGRAPHE DMR+ REV 1 pim 5128706–1–100 CHAPTER 4 – ADDITIONAL PLANNING AIDS 4–1...
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GE Healthcare SENOGRAPHE DMR+ REV 1 pim 5128706–1–100 ILLUSTRATION 4–1 INTERCONNECTION SCHEMATIC A = Input voltage = 480 V single–phase. B = Input voltage = 200/208/220/240/380/415 V single–phase. CUSTOMER GEMS–E SUPPLIED SUPPLIED DATAFLASH (OPTION) STEREOTIX 2 (OPTION) CONTROLLER Dia = 35 mm 1.38”...
GE Healthcare SENOGRAPHE DMR+ REV 1 pim 5128706–1–100 SECTION 1 PRODUCT SHIPPING INFORMATION AIR AND ROAD SHIPMENT PRODUCT/ WEIGHT HEIGHT X WIDTH X DEPTH METHOD OF SHIPMENT COMPONENT POUNDS (daN) 6'36 X 3'. X 7'. SENO DMR 1476 (670) PALLET (1.94 X 0.90 X 2.14)